Written Examination

Senior Executive – Regulatory Affairs

Please write down the answers for below listed questions.

Total Questions: 5

1. Which agency/authority is responsible for auditing Class C & Class D medical devices?
a. Notified body
b. State licensing authority
c. Central licensing authority
d. Sugam

Ans: Notified Body

2. This symbol indicates ___________

a) Sterile
b) Non-sterile
c) Consult instructions for use
d) Caution

Ans: Consult instruction for use

3. Which of the following is an adverse event?

1. My wife has total knee replacement (right knee) on 2019. Three days later she had
burning sensation and went back to the doctor. The doctor removed the dressing and
the skin on either side of the incision looked like 3rd degree burns from the dressing
adhesive. My wife was in tremendous pain. (both burning sensation and actual pain).
He also contacted the manufacturer of Product X and they claimed that my wife was
allergic to the adhesive or she bent her knee too much.

2. In femoral puncture site, Product X took 25 minutes to achieve haemostasis. Tried to

observe haemostasis after 10 minutes but it was still bleeding from puncture site.
Again, compressed for 5 more minutes and checked again but still haemostasis was
not achieved. It took almost 25 minutes to achieve haemostasis.

Ans: 2

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Senior Executive – Regulatory Affairs

4. Please write a response email to your project team’s query on the licensing of product in
india.

Case: Dear Regulatory team,

Is it possible to get the approval of product whose predicate device is not approved in
India? What are the requirements related to predicate devices in India? We just got to
know that our device doesn’t have any similar predicate device approved in India. We
have one predicate which is approved in Europe. Please suggest a way forward.

Ans:
Dear Sir/ Mam,
If the products do not have a predicate in India the processing time will increase and
special committee will be appointed to determine the products safety and efficacy for the
Indian markets
A predicate device must be registered with CDSCO where the manufacture will first
identify the similar products used for same indication/ body contact.
The device must be clinically tested as the applicant has to make an application in MD 26
for the grant of permission, if the trial is complected then the applicant can apply a fresh
registration.

5. Please provide your response to the below case:

Company “A” is a manufacturer of a Medical Device and he outsources the entire

manufacturing of the product to Company “B”. List out the controls that the Company
“A”should exercise over the Company “B”.

Ans:
1) Performing Supplier Audits
2) Performing quality inspection on received products

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 Written Examination
Senior Executive – Regulatory Affairs

3) Retesting all the chemical and material characterization

4) Keeping control sample
5) Traceability
6) Preservation of products by the company B
7) Validation of all the equipment and processes
8) Calibration and maintenance of all gauges and equipment
9) Documentation practice
10) Technical staff list

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